ID

22010

Description

Efficacy Study of Gemcitabine-Paclitaxel to Treat Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00316199

Link

https://clinicaltrials.gov/show/NCT00316199

Keywords

Versions (1)
  1. 5/14/17 5/14/17 -
Uploaded on

May 14, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00316199

English

Eligibility Metastatic Breast Cancer NCT00316199

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients of chinese origin with histologically or cytologically proven diagnosis of breast cancer.
Description

breast cancer, gender, chinese origin

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0152035
unresectable, locally recurrent breast cancer or stage iv disease.
Description

breast cancer stage, unresectable, locally recurrent

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0027646
UMLS CUI [1,3]
C1519810
UMLS CUI [1,4]
C2986682
have at least one measurable lesion as defined by response evaluation criteria in solid tumors (recist) criteria.
Description

response evaluation criteria in solid tumors

Data type

boolean

Alias
UMLS CUI [1]
C1709926
performance status of 0 or 1 on the eastern cooperative oncology group (ecog) scale
Description

ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
treatment with an anthracycline-based chemotherapy regimen in the adjuvant/neoadjuvant setting with subsequent disease relapse.
Description

anthracycline-base chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0282564
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior chemotherapy for unresectable, locally advanced breast cancer or metastatic disease.
Description

breast cancer, unresectable, locally advanced, metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C1519810
UMLS CUI [1,4]
C0677984
UMLS CUI [1,5]
C0027627
concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
Description

concurrent tumor therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009429
UMLS CUI [1,2]
C0920425
known or suspected brain metastasis or second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
Description

brain metastasis, second primary malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0751623
active infection or other serious condition.
Description

infection, comorbidities

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0009488
pregnant or breastfeeding.
Description

pregnancy, breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Metastatic Breast Cancer NCT00316199

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
breast cancer, gender, chinese origin
Item
female patients of chinese origin with histologically or cytologically proven diagnosis of breast cancer.
boolean
C0678222 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0152035 (UMLS CUI [3])
breast cancer stage, unresectable, locally recurrent
Item
unresectable, locally recurrent breast cancer or stage iv disease.
boolean
C0678222 (UMLS CUI [1,1])
C0027646 (UMLS CUI [1,2])
C1519810 (UMLS CUI [1,3])
C2986682 (UMLS CUI [1,4])
response evaluation criteria in solid tumors
Item
have at least one measurable lesion as defined by response evaluation criteria in solid tumors (recist) criteria.
boolean
C1709926 (UMLS CUI [1])
ecog
Item
performance status of 0 or 1 on the eastern cooperative oncology group (ecog) scale
boolean
C1520224 (UMLS CUI [1])
anthracycline-base chemotherapy
Item
treatment with an anthracycline-based chemotherapy regimen in the adjuvant/neoadjuvant setting with subsequent disease relapse.
boolean
C0392920 (UMLS CUI [1,1])
C0282564 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
breast cancer, unresectable, locally advanced, metastatic
Item
prior chemotherapy for unresectable, locally advanced breast cancer or metastatic disease.
boolean
C0392920 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1519810 (UMLS CUI [1,3])
C0677984 (UMLS CUI [1,4])
C0027627 (UMLS CUI [1,5])
concurrent tumor therapy
Item
concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
boolean
C0009429 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
brain metastasis, second primary malignancy
Item
known or suspected brain metastasis or second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
boolean
C0220650 (UMLS CUI [1])
C0751623 (UMLS CUI [2])
infection, comorbidities
Item
active infection or other serious condition.
boolean
C0009450 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
pregnancy, breast feeding
Item
pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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